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First Ever Celiac Disease Vaccine Trials Underway in Australia

Celiac.com 04/06/2009 - Celiac sufferers around the globe are anxiously awaiting word from Australia, as the world's first vaccine trials for the treatment of celiac disease get underway in Melbourne. In April, Bob Anderson, of the Walter and Eliza Hall Institute of Medical research, will begin the initial phase of the first-ever trials for a celiac vaccine that, if successful, might just mean the end of gluten-free diets for those with celiac disease.

The treatment has been successful in mice and is now ready to be tested on humans. In this initial phase, 40 volunteers with celiac disease will receive doses of the vaccine over an 11-month period to determine that it will cause no harm. Once researchers make sure the vaccine is safe, they will begin phase II trial, wherein they give vaccine doses to trial subjects and evaluate their responses to gluten challenges to determine the efficacy of the vaccine. Evaluation will include an examination of immune response and intestinal condition to determine the level of gluten tolerance.

The vaccine therapy involves repeatedly injecting solutions of gluten at increasing concentrations. The goal is to reduce and ultimately eliminate gluten sensitivity slowly, in a manner similar to common allergy desensitization treatments. The road to the development of this treatment has not been easy. Dr. Anderson is that rare combination of medical doctor (gastroenterologist) and PhD scientist who is able to develop practical treatments from bedside observations. After struggling to gain funding throughout his research career, he eventually patented his vaccine and co-founded Nexpep in an effort to develop the vaccine on his own. Because, like common dust and hay fever allergy therapies, this treatment approach may allow people with celiac disease to actually consume the gluten that produces the toxic reaction and reduce or even eliminate that reaction via vaccination. This approach will also serve as a model for a vaccine approach for other immune conditions such as type 1 diabetes, rheumatoid arthritis and multiple sclerosis.

Until recently, doctors thought celiac disease was rare. But according to statistics, it is twice as common as type1 diabetes or breast cancer. Celiac disease is now known to strike one per cent of Americans, but although modern blood testing has made early detection accurate and efficient, most people with celiac disease still do not know that they have it. Just 3% of sufferers have been diagnosed, leaving nearly 3 million people undiagnosed, and therefore unable to benefit form simple treatment in the form of a gluten-free diet. Long-term risks for untreated celiac disease include malnutrition, infertility, osteoporotic fractures, liver failure and various cancers. Symptoms can vary between individuals, with some experiencing no symptoms at all, even though damage to the bowel and general health still occurs whether or not symptoms are present.

Presently, long-term monitoring of dietary compliance for celiac patients is haphazard at best, and standards for gluten-free products have yet to take effect in the USA and other countries. Geoff Withers, director of pediatric gastroenterology at Brisbane's Royal Children's Hospital, points out that a gluten-free diet is "notoriously difficult. It is expensive and lifelong, and comes at a cost to the individual." Even treatment with a gluten-free disease is no panacea. People on gluten-free diets routinely suffer from a deficiency of certain vitamins, especially B vitamins. Roughly half of those following gluten-free diets have impaired intestinal healing due to compliance issues, and that means they are in danger of associated risks which include cancer.

A successful vaccine could have massive consequences for treatment of celiac disease, and might radically improve the lives of those with the condition.

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Guest Alex

'Geoff Withers, director of pediatric Gastroenterology at Brisbane's Royal Children's Hospital, points out that a gluten-free diet is notoriously difficult. It is expensive and lifelong, and comes at a cost to the individual.'

I disagree with that statement. There are two choices you can make if you are gluten-sensitive:

1. Eat the same crap you ate before, but pay twice as much for the gluten-free version, and still have to worry every single meal whether it's really gluten-free.

or

2. Change permanently to the Paleo Diet (eat meat, vegetables, fruit, nuts/seeds) and never have to worry again because those foods are by nature gluten-free.

Plus, you reap tremendous health benefits from eating this way and cutting out the bad carbs, sugar, dairy, and grains.

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Guest Sue H of Aurora, IL, USA

This brought a huge smile on my face - that someone in the medicine/research field actually cares about us to develop a vaccine! When my teenage son was tested for a full array of food allergies at the Allergy Associates of LaCrosse, WI, he was given sublingual allergy immunotherapy or 'allergy drops' to desensitize his food allergies which included gluten (FYI - he did not test positive for celiac despite family history of celiac disease). He continues to eat gluten here and there while taking daily drops and the two of us family members with celiac disease have noticed that his reactions to gluten have progressively become much more tolerable (unlike ours). With people like Dr. Anderson and my son's allergist, Dr. Kroker, will indeed figure out ways to assist our immune system in tolerating gluten. I will be anxious to learn of Dr. Anderson's results.

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Guest Merovign

Do I completely misunderstand Celiac disease? An autoimmune reaction in the intestine, right?

I'd like to know a LOT more about the tests - it seems that this would be attempting to either deaden the symptoms or deaden the immune system. Doesn't a vaccination trigger a MORE efficient immune system response?

I look forward to improved treatment or even a cure as much as anyone, it just seems that a lot of the "cure" talk is about symptoms (and not damage) or short-term effects.

Guest eilam

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Guest Daniel Sanelli

This is what confuses me. Celiac disease is an autoimmune disease. The vaccine may calm the affects of the gluten on the immune system, but this isn't the only trigger. It sounds like a good cure for gluten sensitivity, but I'm not sure I understand how this is a cure for Celiac.

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Guest Morgen P

Honestly, being 18 years old and being diagnosed with this disease at the age of 15... Is something, either it treats it completely or just helps with it... ANYTHING is great! I've always loved my breads and such & knowing that in the near future I might actually be able to have a delicious slice of Domino's Pizza or even my best friend's birthday cake... It's simply a blessing!

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Guest Morgen P

'Geoff Withers, director of pediatric Gastroenterology at Brisbane's Royal Children's Hospital, points out that a gluten-free diet is notoriously difficult. It is expensive and lifelong, and comes at a cost to the individual.'

I disagree with that statement. There are two choices you can make if you are gluten-sensitive:

1. Eat the same crap you ate before, but pay twice as much for the gluten-free version, and still have to worry every single meal whether it's really gluten-free.

or

2. Change permanently to the Paleo Diet (eat meat, vegetables, fruit, nuts/seeds) and never have to worry again because those foods are by nature gluten-free.

Plus, you reap tremendous health benefits from eating this way and cutting out the bad carbs, sugar, dairy, and grains.

It's easy, affordable, safe, and the healthiest nutrition possible.

But, those diets don't help people that have gained other autoimmune diseases because of celiac. Such as allergies to corn, rice, dairy products, etc.

Guest charlie

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Guest Rebbecca

'Geoff Withers, director of pediatric Gastroenterology at Brisbane's Royal Children's Hospital, points out that a gluten-free diet is notoriously difficult. It is expensive and lifelong, and comes at a cost to the individual.'

I disagree with that statement. There are two choices you can make if you are gluten-sensitive:

1. Eat the same crap you ate before, but pay twice as much for the gluten-free version, and still have to worry every single meal whether it's really gluten-free.

or

2. Change permanently to the Paleo Diet (eat meat, vegetables, fruit, nuts/seeds) and never have to worry again because those foods are by nature gluten-free.

Plus, you reap tremendous health benefits from eating this way and cutting out the bad carbs, sugar, dairy, and grains.

It's easy, affordable, safe, and the healthiest nutrition possible.

I agree with the paleo diet, although it can be hard at times, but well worth it, i have been on a Paleo diet for three weeks, as I am celiac and was getting pain, and feeling sick from eating to much gluten free grains, such as rice and corn based products. So i feel great now, pain free, not feeling sick anymore and full of energy. Plus it forces me to eat more fruit and vegetables, which we tend not to eat enough off, with our busy lifestyles.

About Me

Jefferson Adams earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in biology, anatomy, medicine, and science. He previously served as Health News Examiner for Examiner.com, and provided health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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Celiac.com 09/10/2012 - Last year, ImmusanT's Nexvax2 celiac disease vaccine passed its phase 1 clinical trials in Australia and New Zealand, causing a stir of hope and anticipation within the celiac disease community. It will still be a while before the vaccine is available to the public, but yesterday ImmusanT announced that it commenced phase 1b clinical trials in New Zealand and Australia and phase 1 clinical trials in the U.S.
New Zealand and Australia's phase 1b randomized, placebo-controlled, double-blind study will follow on the prior phase 1 trials and involve approximately 84 celiac disease patients on gluten-free diet at four study sites throughout the two countries. The focus of the study will be on evaluating safety, tolerability and pharmacokinetics (what the body does to the drug), as well as determining appropriate doses for subsequent studies.
In the U.S., the phase 1 randomized, placebo-controlled, double-blind study will involve 30 celiac disease patients on gluten-free diet at approximately four test sites throughout the country. This preliminary study will evaluate safety, tolerability, and pharmacokinetics of the drug for American subjects.
Patients in both studies will have confirmed diagnosis of celiac disease, as well as the HLA-DQ2 gene (which approximately 90% of celiac disease sufferers carry). Blood tests for gluten-reactive T cells will also be used to select suitable test subjects.
The studies will employ an intradermal injection vaccine delivery solution by BD.
The Nexvax2 vaccine is intended to restore the body's ability to tolerate gluten. It is hoped that antigen-specific T cells will be the key to allowing patients to consume gluten freely with no adverse effects. If all goes well during this and subsequent clinical trials, we could have a cure for celiac disease in the not-too-distant future.
Source:
http://www.sacbee.com/2012/09/04/4784050/immusant-initiates-clinical-trials.html

Rider Settles Dining Complaint Over Celiac Disease ... student who has celiac disease, which is triggered by consumption of gluten. ... and create a “preorder” option for students with food allergies, Carpenito said in a statement.
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